Pharmaceutical Trademarks 2018/2019 - A Global Guide - Mexico
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Mexico
OLIVARES
Victor Ramirez and Erwin Cruz
Pharmaceutical
Trademarks
2018/2019
A Global Guide
Mexico
OLIVARES
Authors
Victor Ramirez and Erwin Cruz
Selection, clearance and registration Opposition system
Regulatory bodies and requirements The IP Law was amended to introduce an
The Industrial Property Law (IP Law) and opposition system in 2016. The opposition
its Regulations regulate trademarks in system works in parallel with the trademark
Mexico. Mexico has acceded to the following prosecution system, as follows:
international treaties relevant to trademark • The trademark application will be published
protection: in the IP Gazette no later than 10 working
• the Paris Convention for the Protection of days after its filing date.
Industrial Property Rights; • Third parties can file observations against
• the North American Free Trade Agreement an application within one month (non-
(NAFTA); extendable) of publication. However,
• the Agreement on Trade-Related Aspects observations neither suspend prosecution
of Intellectual Property Rights; and of the application nor grant legal standing
• the Madrid Protocol for trademark within this prosecution.
registration. • IMPI will publish a list of applications for
which observations have been received.
The exclusive right to a trademark is
obtained through registration with the Although IMPI is not obliged to assess
Mexican Institute of Industrial Property observations, applicants can reply to these
(IMPI). observations within one month of publication.
All visible signs can be protected, Regardless of observations, IMPI will decide
provided that they are sufficiently on the grant or refusal of trademark applications.
distinctive and can distinguish the goods
or services to which they apply from Marketing authorisation
others in the same class (Article 89 of the Manufacturers must obtain marketing
IP Law). authorisation to sell any medicine or certain
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MEXICO OLIVARES
medical devices. The relevant authority Health Regulations).
is the Federal Commission for Protection • In use and marketing, medicines must be
against Sanitary Risk (COFEPRIS), which identified by their distinctive and generic
approves the names of medicines – referred names (Article 225 of the Health Law).
to as ‘distinctive names’ in the Health Law • The distinctive name must not refer
and its Regulations. In order to apply for to the composition of the product
a marketing authorisation, the distinctive or its therapeutic action. Vaccines
name of the product must be pre-approved and biological products excepted, no
by COFEPRIS (Article 2(iv) of the Health indications may relate to diseases,
Regulations). syndromes, symptoms, anatomical data
The Health Law and the Health or physiological phenomena (Article 225
Regulations specify the requirements for of the Health Law).
distinctive names. The principal rules for the • A proposed distinctive name will be
names of medicines are as follows: rejected if it is identical to the previous
• ‘Distinctive name’ means the name or name of another approved medicine
trademark assigned to a pharmaceutical (Article 23 of the Health Regulations).
product in order to distinguish it from • Under the ‘three-letter rule’, the
other similar products (Article 2(iv) of the difference between the proposed name
Victor Ramirez Erwin Cruz
Senior associate Associate
victor.ramirez@olivares.mx erwin.cruz@olivares.mx
Victor Ramirez joined OLIVARES in 1999 and Erwin Cruz has been helping clients to add
completed a postgraduate major in IP law at value to their businesses and projects in
the Pan-American University in Mexico City in Mexico since 2008, when he became part
2005. He attended the IP Summer Institute at of the OLIVARES life science law group. He
the Franklin Pierce Law Centre in 2007. achieves this not only by obtaining exclusive
Mr Ramirez’s work at OLIVARES focuses rights for clients, but also by developing
on counselling, lobbying and prosecuting and successfully implementing strategies
administrative proceedings on IP and regulatory to enforce these rights and fair trade rules
matters such as marketing, advertising and against potential infringers.
labelling issues before government agencies Mr Cruz provides highly qualified
such as the Mexican Trademark and Patent regulatory assistance related to marketing,
Office, the Federal Commission for Health Risks labelling and advertising. He has extensive
and the Consumer’s Attorney General Office. expertise and has written several articles
He is also an experienced litigator, assisting about litigation and regulations relating to
clients from a number of industries to challenge the pharma, agro and software industries. He
before the courts the inspections, infringement regularly participates in international and
proceedings and seizures or fines imposed by national conferences.
government agencies.
45 | Pharmaceutical Trademarks 2018/2019 www.WorldTrademarkReview.com
OLIVARES MEXICO
IMPI examiners usually consider the three-letter rule
when analysing the similarity of pharmaceutical
trademarks, although it is not binding on them
and the previous name should be at The COFEPRIS system enables
least three letters in each word to prove pharmaceutical companies to obtain a pre-
dissimilarity (Article 23 of the Health approval certificate for distinctive names,
Regulations). valid for 90 days, which is useful for any
• A distinctive name can be used for marketing authorisation. However, the
pharmaceutical products that have the system allows only 10 certificates to be
same active ingredient and have been granted per company and such certificates
approved by the same laboratory, but have do not bind COFEPRIS, which can still reject
different pharmaceutical forms or doses marketing authorisation for a pre-approved
(Article 23 of the Health Regulations). distinctive name that COFEPRIS may
ultimately consider is unacceptable.
Practical issues Such rejection may be contested before the
There is no clear link between the IP Law federal courts.
and the Health Law and their regulations The new opposition system might be
regarding conflicts between registered useful for pharmaceutical trademark owners
trademarks and marketing authorisations or to detect and raise objections before IMPI
distinctive names. based on the Health Law and its Regulations.
IMPI examiners usually consider
the three-letter rule when analysing the Confusion with INNs
similarity of pharmaceutical trademarks, Including international non-proprietary names
although it is not binding on them. (INNs) or their stems as part of pharmaceutical
However, the Health Regulations do not product trademarks creates conflicting
require COFEPRIS to consider senior situations.
trademark registrations (for pharmaceutical The Health Law (Article 225) expressly
products) when examining the similarity forbids the use of pharmaceutical trademarks
of distinctive names using its own software that clearly resemble INNs and the IP Law
developed to apply the three-letter rule. (Article 90(II)) prohibits registration of generic
This inconsistency has had unfortunate names. Accordingly, IMPI has no legal basis for
consequences, including contrary decisions refusal of a trademark that comprises a stem
of IMPI and COFEPRIS regarding the or an INN and additional distinctive elements
likelihood of confusion of trademarks and that make the trademark registrable as a whole.
distinctive names. INNs are generic and cannot be treated
Further, IMPI and COFEPRIS have otherwise, which makes it impossible
different databases. The IMPI database for IMPI to assess the likelihood of
comprises all trademark applications and confusion between pharmaceutical trademarks
registrations that have been filed with and INNs.
the agency or its predecessors, while the IMPI thus faces a challenge in following the
COFEPRIS database contains only the World Health Organisation’s recommendations
distinctive names allowed for medicinal to safeguard the proper use of INNs and to
products, regardless of whether they are avoid the registration of trademarks derived
in use. therefrom.
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The IP Law does not recognise marks comprising
sounds, smells, tastes or textures, since they are not
visible. Current renegotiations over NAFTA would
introduce improvements in this regard
Non-traditional trademarks COFEPRIS. Medicines must have marketing
Article 89 of the IP Law provides that authorisation. Under certain circumstances
only visible words, names and designs, (eg, clinical trials and orphan drugs),
including three-dimensional (3D) marks, are the import of a minimal quantity of
registrable as trademarks. products without marketing authorisation
Under the IP Law, colours alone are can be approved.
unregistrable, “unless they are combined or In relation to trademarks, parallel imports
accompanied by elements such as symbols, are allowed, provided that the product was
designs or denominations that give them a legally introduced in the country of origin
distinctive character”. Thus, combinations and the trademark is owned by the same
of two or more colours can be registered company or group of companies in Mexico.
as trademarks, regardless of the form or The packaging and labelling of
surface on which they are applied. pharmaceuticals are governed by the Health
Article 89 of the IP Law establishes that Law and its Regulations and require approval
3D signs have elements that can constitute by COFEPRIS. Altering or modifying
a trademark and are thus registrable. the authorised packaging or labelling of
However, a 3D mark must: approved pharmaceutical products can be
• not be in the public domain; considered a criminal offence (Article 464ter
• not have fallen into common use; of the Health Law).
• be sufficiently original to be easily
distinguished; and Anti-counterfeiting and enforcement
• not have a shape that represents the A database has been created, managed by
product or is required by its function. Customs in coordination with IMPI, which
contains the registered trademarks of owners
Motion marks cannot be protected. interested in monitoring their rights at the
The IP Law (Article 90(1)) establishes 49 customs checkpoints at the country’s
that names, figures or forms expressed borders, ports, bus and train stations
in a dynamic way cannot be registered as and airports.
trademarks, regardless of whether they are Regarding medicines, pharmaceutical
visible. substances, chemicals and active
The IP Law does not recognise marks pharmaceutical ingredients (APIs), Customs’
comprising sounds, smells, tastes or efforts are limited to detecting prohibited
textures, since they are not visible. Current drugs and narcotics. The next step is to
renegotiations over NAFTA would introduce strengthen IP protection for patents within
improvements in this regard. Mexico, particularly for those that protect
pharmaceutical products.
Parallel imports and repackaging Customs may collaborate with rights
Any import of medicines, health or holders to detect and seize APIs based on
pharmaceutical products – or raw materials IMPI-ordered border measures. Thanks to
for such products – must be approved by cooperation between Customs and IMPI,
47 | Pharmaceutical Trademarks 2018/2019 www.WorldTrademarkReview.comOLIVARES MEXICO
bulk border seizures of patented APIs have search warrant from a federal court and
taken place. can intervene only in cases involving the
A trademark registration can be enforced falsification of goods for which IP rights
against alleged infringers in two ways: are held.
• If the infringer uses a confusingly Proceedings begin with the mandatory
similar or identical trademark for filing of a special type of criminal complaint.
identical or similar goods or services, In the context of an investigation, infringing
an infringement action can be brought goods can be seized without a search or
before IMPI. warrant order if they are publicly available.
• If the infringer uses an identical However, if they are stored on private
trademark for identical goods or services, property, a search or warrant order must
a criminal action can be brought before be obtained.
the Attorney General’s Office. A raid may take place within 15 to 45
days, depending on the type of premises
Infringement action to be searched and its distance from
Infringement actions are filed before IMPI, Mexico City.
which is an administrative authority rather Indictments may be issued within
than a court. Once admitted for prosecution, 48 hours of execution of a search or
IMPI serves notice of the infringement warrant order if a suspect is arrested; it
action on the alleged infringer, granting it 10 may take longer if the request relates to
working days to reply. organised crime. If no suspect is arrested,
On request, IMPI can impose an indictment may be issued within
provisional injunctions before the filing approximately two months. During that
of an infringement claim or during the time, the seized goods are stored in
prosecution of the case. government warehouses.
Both the claimant and the alleged On completing the investigation, the
infringer must submit evidence at the federal prosecutor will bring the case before
time of filing or responding to the claim. a federal court.
Subsequently, IMPI grants the parties a
common term to file closing allegations. Advertising
IMPI’s decision is subject to appeal before Regulatory framework
the Federal Court for Administrative Affairs, The primary legislation for the advertising
whose decision can be further appealed of medicinal products is the Health Law and
before the circuit courts. the Health Law Advertising Regulations,
Infringers can incur penalties ranging supplemented by COFEPRIS guidelines.
from a fine of up to 20,000 times the Industry codes of practice complement
minimum wage (around $100,000) to closure these regulations. The Council of Ethics
of their businesses (Article 214 of the IP and Transparency of the Pharmaceutical
Law). Repeated infringement is a criminal Industry (CETIFARMA) has issued various
offence (Article 223 of the IP Law). self-regulatory codes. Affiliate members of
The IP Law establishes that the damages the National Chamber of the Pharmaceutical
awarded to the owner of an infringed IP right Industry must adhere to the codes and
should not be less than 40% of the sales CETIFARMA supervises compliance. The
of the infringing product at the consumer Advertising Council also issues opinions.
retail price. This provision is currently under Other general legislation may be relevant
review by the Supreme Court. to the advertising of medicinal products
– in particular, the Federal Law for the
Attorney General’s Office Protection of Consumers and the IP Law.
The federal prosecutor at the Attorney The most important rule to be considered
General’s Office also investigates IP crimes in connection to consumer protections is
and can use force during raids related that information or advertising relating
to IP rights. However, it must obtain a to pharmaceuticals that is disseminated
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The Code of Good Promotion Practices
requires that the information provided to
healthcare professionals be accurate,
balanced, fair and objective, and sufficiently
COFEPRIS has been complete for them to form their own
increasing its monitoring opinion of the therapeutic value of the
corresponding medicine.
of online ads for
Monitoring
medicinal products, COFEPRIS can order the suspension of
which traditionally have advertising activity in breach of the legal
framework. The responsible party and
been less stringently the media channel must comply within
24 hours.
monitored than television The penalties for failure to comply
or radio ads with the advertising rules are suspension
of advertising activities by the responsible
party or the media and a fine of between
2,000 and 16,000 times the minimum wage
through any medium must be true, verifiable (around $10,000 to $80,000).
and free of text, dialogue, sounds, images,
trademarks, denominations of origin and Generic substitution
other descriptions that induce or may induce Under the Health Regulations, a physician
an error or confusion because they are must prescribe medicines and biologics
deceptive or abusive. using their INNs and may choose to indicate
CETIFARMA’s codes further require the preferred distinctive name. Thus,
the provision of accurate and objective patients may receive from the pharmacist
explanations of the characteristics, any product with the same active ingredient.
functions, advantages and disadvantages of A review of possible mechanisms to
pharmaceutical products and services. prevent automatic switching from biologic
innovators to biosimilars in view of potential
Non-prescription medicines health issues is pending.
According to the Health Law Advertising
Regulations, only non-prescription Online issues
medicines can be advertised to the general Under the Health Regulations, medicines
public, subject to approval by COFEPRIS. must be made available through authorised
The media must require certified copies of pharmacies and can be sold only to
the relevant marketing authorisations for the patients with a physician’s prescription,
corresponding medicines before publishing especially antibiotics (except over-the-
or broadcasting related ads. counter products).
According to its internal guidelines, Electronic advertising falls under the
COFEPRIS does not approve ads comparing general advertising rules in Article 2 of the
products with the same therapeutic Health Regulations. COFEPRIS has been
indication or questioning the quality of increasing its monitoring of online ads for
products with marketing authorisation. medicinal products, which traditionally
have been less stringently monitored than
Prescription medicines television or radio ads.
Prescription medicines can be advertised Pharmacies must obtain permission
to healthcare professionals. However, to operate on health grounds and other
this advertising can be done only through stores are forbidden from marketing
specialised media and must be based on prescription medicines.
medical prescription information. The Code of Good Promotion Practices
49 | Pharmaceutical Trademarks 2018/2019 www.WorldTrademarkReview.comOLIVARES MEXICO
requires the adoption of measures to ensure Local Dispute Resolution Policy action
that the promotion of prescription medicines may apply regarding cybersquatting. It is
on websites is accessible only to healthcare a variation of the Uniform Domain Name
professionals. Such websites must carry Dispute Resolution Policy established by the
a warning stating that they may be used Internet Corporation for Assigned Names
only by healthcare professionals allowed to and Numbers and the World Intellectual
prescribe drugs. Property Organisation. WTR
Domain names
As in the rest of the world, in Mexico the
protection of domain names is a new issue
that requires attention, as it has triggered
legal questions of many sorts.
For example, one common question is
whether a domain name can be protected as
a trademark. In principle, it is possible, as
domain names are capable of distinguishing
products or services that originate from the OLIVARES
same source and pertain to the domain name Pedro Luis Ogazon 17
holder. Domain names do not merely serve Col San Angel
as URLs. Of course, to qualify for trademark Mexico City 01000
protection, the domain name – or at least Mexico
the second portion thereof – must meet the Tel +52 55 5322 3000
principles and general standards of the IP Fax +52 55 5322 3001
Law and be duly registered with IMPI. Web www.olivares.mx
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